NCT00217555

Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.

Detailed description

OBJECTIVES: Primary * Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer. * Determine the response rate in patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. Secondary * Determine the duration of progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond documentation of CR. Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cavity Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	topotecan hydrochloride

Timeline

• Start date: 2002-07-01
• Primary completion: 2006-02-01
• First posted: 2005-09-22
• Last updated: 2010-09-21

Locations

1 site across 1 country: United States